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Executive Summary

SERONO'S METRODIN IS APPROVED FOR SECOND-LINE TREATMENT OF INFERTILITY in women with polycystic ovarian syndrome. The package insert for Metrodin (human follicle stimulating hormone), approved by FDA on Sept. 18, states: "Metrodin and hCG [human chorionic gonadotropin] given in a sequential manner are indicated for the induction of ovulation in patients with polycystic ovarian disease who have an elevated LH/FSH ratio and who have failed to respond to adequate clomiphene citrate therapy." Patients must meet the following criteria before going on Metrodin treatment: a gynecologic and endocrinologic evaluation, exclusion of primary ovarian failure or early pregnancy, cervical dilation and curettage, and evaluation of the husband's fertility potential. Adverse reactions with Metrodin have occurred in "approximately 1 in 10" patients; the most common reactions are hyperstimulation syndrome, ovarian enlargement, abdominal pain, and rash or swelling at the site of injection, the insert said. FDA classified Medtrodin as a 2 C product (a new salt or esther representing little or no therapeutic gain). In a press release, Serono maintained that Metrodin is the first product for treating infertility approved by the FDA in five years. Metrodin will become available to wholesalers on Nov. 1 at a price of $35.20 per amp.

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